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The effects of nutritional supplements on postprandial nitric oxide bioactivity in abdominally obese me

Completed
Conditions
Insulin Resistance Syndrome
Syndrome X
10013317
Metabolic Syndrome
Registration Number
NL-OMON46749
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

- Men
- Aged between 40-70 years
- Waist circumference >= 102
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L
- Stable body weight (weight gain or loss < 3 kg in the past three months)
- Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- No current smoker
- No diabetic patients
- No familial hypercholesterolemia
- No abuse of drugs
- No more than 3 alcoholic consumptions per day
- No use of medication known to treat blood pressure, lipid or glucose metabolism
- No use of an investigational product within another biomedical intervention trial within the previous 1-month
- No intolerance or allergy to the ingredients of the intervention products (e.g. lactose or gluten)
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Willingness to give up the use of antibacterial mouth wash or antibacterial toothpaste, chewing-gum and tongue-scraping on the morning of each experimental test day

Exclusion Criteria

- Women
- Fasting plasma glucose >= 7.0 mmol/L
- Fasting serum total cholesterol >= 8.0 mmol/L
- Current smoker, or smoking cessation <12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use medication known to treat blood pressure, lipid or glucose metabolism
- Use of an investigational product within another biomedical intervention trial within the previous 1-month
- Intolerance or allergy to the intervention products (e.g. lactose or gluten)
- Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
- Not willing to give up being a blood donor from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Measurements will be performed before and two hours after consumption of the<br /><br>high fat milkshake and the five interventional products. The primary endpoint<br /><br>is the difference in postprandial change in FMD between the five interventional<br /><br>products. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes are the postprandial effects of the interventional products<br /><br>on retinal microvascular function, plasma cGMP (as indicator of nitric oxide<br /><br>bioactivity), plasma markers for low-grade systemic inflammation and<br /><br>endothelial dysfunction, blood pressure, and serum lipid and plasma glucose<br /><br>metabolism.</p><br>
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